Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with
the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of
five years.
2N-13-2: A Randomized, Phase 3 Study of Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced Non-Small-Cell Lung Adenocarcinoma
This is an open-label, multicenter, randomized Phase 3 study of patients with Stage IIIB/IV NSCLC of adenocarcinoma histology.Primary Objective is to evaluate and compare overall survival (OS) in non-small cell lung cancer (NSCLC) patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone.Ganetespib is a novel synthetic small molecule that binds to the adenosine triphosphate (ATP) pocket in the N-terminus of Hsp90 and demonstrates significant activity for down-regulating Hsp90 client protein levels. This ability to impact a broad array of important oncogenes and cell signaling kinases is reflected in ganetespibs activity across a wide variety of tumor cell types.Patients will be randomized in a 1:1 ratio to receive either ganetespib in combination with docetaxel or docetaxel alone. The study will enroll approximately 500 patients, 12 from USC, over a planned 12-month period, and patients will be randomized into one of two treatment arms.
An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)
VTI-212 is an open-label, multicenter, historically-controlled study of subjects with acute
liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the
study will receive ELAD treatment in addition to standard of care treatment for ALF. The
outcomes of these subjects will be compared with matched historical controls drawn from
existing databases.
Subjects will undergo ELAD treatment for a minimum of 3 days (72 hours). It is recommended
ELAD treatment be continued up to 10 days (240 hours).
Following ELAD treatment, subjects will continue standard medical therapy as defined by the
institution and be followed through Study Day 28.
Subjects' diagnosis of ALF will be attributed to one of the following:
1. FHF (acute liver failure with no preexisting liver disease);
2. Primary Graft Non-Function (PNF);
3. Surgically-Induced Liver Failure (including subjects with small for size liver
transplants, living donor liver transplants, and subjects with risk of ALF following
liver cancer surgery.
Screening evaluations and assessments will be completed for subjects and reviewed against
inclusion/exclusion criteria.
Enrollment will define the time of study entry (Hour 0, Study Day 1, study baseline) and
inclusion in the ITT population. Subjects will be evaluated throughout the 28-day study
period.
If standard medical therapy, as defined by the institution and this protocol is consistent
with discharging the subject home, then the subject should be discharged. Prior to
discharge, the subject will be advised to attend all follow-up visits.
An extension of this study, VTI-212E, will provide additional ELAD survival data, as
available, through VTI-212 study termination (after the last surviving enrolled ELAD subject
completes Study Day 28). This registry protocol segment of VTI-212 extends the safety
monitoring period to 5 years to assess survival, incidence and characterization of tumor (in
particular hepatocellular tumor), incidence of liver transplant, and assess quality of life
using a standard, validated questionnaire.
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